Device recall
Z-3088-2024: smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with…
FDA device recall · Class I · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-3088-2024 |
|---|---|
| Recall event | 95016 |
| Product | smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural… |
| Product code | BTO |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K173384 |
| FEI number | 3012307300 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database